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One year after de-monopolisation

On 1 July 2009, Sweden implemented the Act on Sales of Medicinal Products, (2009:366) (ASMP) which allows entities other than the state-owned Apoteket AB to own and operate pharmacies. The aims of the Act are inter alia to increase access to medicines; to drive down prices for nonprescription and prescription medicines; and to achieve a better control over the public costs for reimbursement prices. This was followed a few months later in November 2009 by the Act on Trade in Certain Non-Prescription Medicines (2009:730), which allows the sale of certain non-prescription medicines outside the pharmacies.

Under the ASMP, there is no longer any government stipulation as to the pricing of non-prescription medicines. However, the Swedish Dental and Pharmaceutical Benefits Agency (the Agency), in accordance with the Act on the Pharmaceutical Benefits (2002:160), still regulates the pricing of prescription medicines and has the remit to determine whether a pharmaceutical product (or dental care procedure) shall be subsidised by the state and, thus, sets the prices. Different products are handled differently by the Agency:

original products - the Agency sets a maximum purchase price for the pharmacies, and the sales price to consumers;

parallel imported products - the Agency sets maximum prices for the sale to both the pharmacies, and to consumers; and

generic products – the Agency sets a fixed purchase price for pharmacies and for consumers.

One year later, around 15 new players have entered the Swedish market for pharmacies, and certain non-prescription medicines are now being sold by supermarkets, gas stations etc. However, according to a newspaper study, the changes have not (yet) led to any pressure on prices for medicines.

The Swedish Medical Products Agency has taken actions against the marketing of non-prescription medicines in a number of cases due to misleading marketing, and marketing, which according to the MPA, does not promote the appropriate use of the product – for example, headache tablets have been marketed as a “happy in foods product” (Sw. matglad vara) and have been exposed in connection with candies.

The Pharmaceutical Benefits Agency has also taken action against the newly established pharmacies after it became aware that the consumers have been able to use ‘bonus cards’ when buying prescription medicines. According to the Agency, this is a breach of the Act on the Pharmaceutical Benefits (2002:160)as no discount may be given on prescription medicines.

Compare jurisdictions:Life Sciences: Product Regulation and Liability

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